JP2015523868A - Multi-directional flexible wire harness for medical devices - Google Patents

Abstract

A wire harness for a medical device includes a wiring bundle, a distal flex circuit, and a proximal flex circuit. The wiring bundle includes a plurality of twisted pair wirings and shields that operably or conductively connect the distal flex circuit to the proximal flex circuit. The distal flex circuit may be configured to operably or conductively connect to an electrically controlled object disposed at the distal portion of the medical device. The proximal flex circuit may be configured to operably or conductively connect to the electrical connector.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of US Provisional Application No. 61 / 333,641 ('641 application) filed May 11, 2010, US Priority to US patent application No. 13 / 465,655 ('655 application) filed May 7, 2012, which is a continuation-in-part of application 13 / 105,646 (' 646 application). Insist. This application also claims the benefit of US Provisional Application No. 61 / 621,814 (the '814 application) filed April 9, 2012. The '655,' 646, '641 and' 814 applications are all hereby incorporated by reference as if set forth herein in their entirety.

  The present disclosure relates generally to the field of medical devices including medical devices for introduction into the body, such as catheters, and other operable medical devices.

  Catheters and sheaths having a flexible tubular body with a deflectable distal end and a control handle for deflection control of the distal end are commonly used in connection with many non-invasive medical procedures. The For example, intracardiac echocardiography studies use a catheter having one or more ultrasound transducers along the distal end of the body. The distal end of the catheter body is typically placed in the patient's heart and an ultrasound transducer may provide signal data. This signal data can be used to generate image data that visualizes intracardiac visualization, navigation and mapping, intracardiac structures, and cardiac blood flow. In general, an ultrasonic transducer may comprise a piezoelectric element or a plurality of piezoelectric elements. Each piezoelectric element may have a relatively thin conductive wire attached to the piezoelectric element, and the wire may extend through the catheter body and ultimately to an electronic control unit (ECU). For example, the conductive wire may extend from the distal end to the proximal end of the catheter, where the wire may terminate with an electrical connector that may be configured to connect with a corresponding socket provided in the ECU. . To bundle multiple wires through the catheter body, the wires may be placed and attached to a flat mylar ribbon.

  In order to obtain a clearer image, an ultrasonic transducer with an increased number of elements can be used. However, the increase in elements also increases the number of associated or corresponding conductive wires that extend through the catheter body. Increasing the number of conductive wires extending through the catheter body can increase stiffness with wiring and reduce the flexibility and operability of the catheter. Further, when wiring is made on a flat ribbon, the flexibility may be inconsistent depending on the direction of bending or bending of the body relative to the position of the ribbon.

  The foregoing discussion is intended only to illustrate the field and should not be construed as negating the scope of the claims.

  In one embodiment, a wire harness for a medical device may include a wiring bundle, a distal flex circuit, and a proximal flex circuit. The wiring bundle may include a plurality of twisted pair wirings (ie, twisted wire pairs) and a shield that surrounds a portion of the plurality of twisted pair wirings, and is operably or conductively a distal flex circuit. May be connected to the proximal flex circuit. The distal flex circuit may be configured to operably or conductively connect to an electrically controlled object disposed at the distal portion of the medical device. The proximal flex circuit may be configured to operably or conductively connect to the electrical connector. The medical device may include an elongated tubular body having a lumen, and the wire harness may pass substantially through the entire lumen of the elongated tubular body of the medical device.

  In one embodiment, a pair of wire harnesses for a medical device may include a first wire harness and a second wire harness, each wire harness comprising a wiring bundle, a distal flex circuit, and a proximal A flex circuit may be included. The wiring bundle may include a plurality of twisted pair wirings and a shield surrounding a portion of the plurality of twisted pair wirings, operatively or conductively connecting the distal flex circuit to the proximal flex circuit. You can do it. The distal flex circuit may be configured to operably or conductively connect to an electrically controlled object and an electrically controlled object assembly that includes at least one flexible printed circuit. An electrically controlled subject assembly may be disposed at a distal portion of the medical device. The proximal flex circuit may be configured to operably or conductively connect to the electrical connector. Each of the first wire harness and the second wire harness may be operatively or conductively connected to the same flexible printed circuit of the electrically controlled target assembly.

  In one embodiment, the plurality of wire harness pairs for the medical device may include a wire harness pair that includes a first wire harness and a second wire harness. Each wire harness may include a wiring bundle, a distal flex circuit, and a proximal flex circuit. The wiring bundle may include a plurality of twisted pair wirings and a shield surrounding a portion of the plurality of twisted pair wirings. The distal flex circuit may be configured to operably or conductively connect to the ultrasonic transducer assembly. The ultrasonic transducer assembly may include an ultrasonic transducer and a plurality of flexible printed circuits operatively or conductively connected to the ultrasonic transducer. The ultrasound transducer assembly may be located at the distal portion of the medical device. The proximal flex circuit may be configured to operably or conductively connect to an electrical connector that may be configured to operably or conductively connect to the electronic control unit. Each of the first wire harness and the second wire harness may be operatively or conductively connected to the same flexible printed circuit of the plurality of flexible printed circuits of the ultrasonic transducer assembly.

  The foregoing and other aspects, features, details, utilities and advantages of the present invention will become apparent upon reading the following description and claims, and upon studying the accompanying drawings.

1 schematically shows a diagram of a system that includes an embodiment of a catheter connected to an electronic control unit (ECU) and a display.

FIG. 2 schematically illustrates a side view of the embodiment of the catheter of FIG. 1 having an ultrasonic transducer assembly, body, handle, electrical connector and wire harness.

1 illustrates embodiments of ultrasonic transducer assemblies in various configurations having multiple wire harnesses.

FIG. 2 shows a side cross-sectional view of the embodiment of the handle of FIG. 1.

1 illustrates an embodiment of a wire harness.

Fig. 3 schematically illustrates a plurality of twisted pair wiring embodiments.

1 illustrates an embodiment of an electrical connector having a plurality of zero insertion force (ZIF) connectors configured to receive a plurality of wire harnesses.

8 illustrates the ZIF connector of FIG. 7 configured to receive the proximal end of the wire harness of FIG.

FIG. 6 schematically illustrates an embodiment of a distal flex circuit and a proximal flex circuit of the wire harness of FIG. 5.

FIG. 6 schematically illustrates another embodiment of a distal flex circuit and a proximal flex circuit of the wire harness of FIG. 5.

  Various embodiments are described herein for various apparatuses, systems, and / or methods. Numerous specific details are described to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments described herein and illustrated in the accompanying drawings. However, one skilled in the art will appreciate that the present embodiments may be practiced without such specific details. In other instances, well-known operations, components and elements have not been described in detail so as not to obscure the embodiments described herein. Those skilled in the art will appreciate that the embodiments described and illustrated herein are non-limiting examples. Accordingly, the specific structural and functional details disclosed herein may be representative, but are not necessarily limited to the scope of the present embodiment, the scope being defined by the appended claims. It can be understood that only defined.

  Throughout this specification, references to “various embodiments,” “some embodiments,” “one embodiment,” or “one embodiment,” etc., refer to particular functions, structures described in connection with this embodiment. Or means that the feature is included in at least one embodiment. Thus, the phrases “in various embodiments,” “in some embodiments,” “in an embodiment,” or “in an embodiment,” etc. appearing throughout this specification are not necessarily all in the same embodiment. Is not mentioned. Furthermore, the particular functions, structures or features may be combined in any suitable manner in one or more embodiments. Thus, the particular functions, structures or features illustrated or described in connection with one embodiment may be combined in whole or in part with the functions, structures or features of one or more other embodiments. Can be combined without restriction if they are not illogical or non-functional.

  It will be understood that the terms “proximal” and “distal” may be used throughout this specification in reference to a clinician operating one end of an instrument used to treat a patient. The term “proximal” means the part of the instrument closest to the clinician, and the term “distal” means the part located farthest from the clinician. It will be further understood that for simplicity and clarity, spatial terms such as “vertical”, “horizontal”, “upper” and “lower” may be used herein with respect to the illustrated embodiments. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting or absolute.

  Referring now to the drawings in which like reference numerals are used to identify identical parts in the various views, FIGS. 1-2 generally illustrate one or more of the catheters 10 performing one or more diagnostic and / or therapeutic functions. Illustrative examples are shown. More particularly, the catheter 10 may include components for performing intracardiac echocardiography (“ICE”) surgery. However, while the following description is directed to an ICE catheter, it should be understood that the subject matter of the present disclosure can find applications associated with a variety of medical devices. As schematically shown in FIG. 1, the catheter 10 includes an ultrasonic transducer assembly 12, a handle 14, a body 16, a wire harness 18, tubing 20 and, for example, by St. Jude Medical. Configured to connect to an electronic control unit (ECU) 23 such as a ViewMate ™ Z or ViewMate ™ II intracardiac ultrasound console via a commercially available compatible ViewFlex ™ catheter interface module. Electrical connector 22 may be included, but is not limited thereto. In one embodiment, the ultrasound console may have a system frequency between 4.5 and 8.5 MHz. In another embodiment, the system frequency may be 3.0-9.0 MHz. In one embodiment, the ultrasound console may have a viewing angle of 90 ° F. In another embodiment, the viewing angle may be 80 ° F. In one embodiment, the ultrasound console may have a maximum field depth of 18 cm. The catheter 10 may have a distal end 24 and a proximal end 26. In one embodiment, the ultrasound imaging mode may include B-mode, M-mode, spectral (pulse wave Doppler) Doppler, and / or color Doppler.

  With reference to FIG. 3, the ultrasonic transducer assembly 12 may include a transducer 28 and a plurality of flexible printed circuits 30. The ultrasonic transducer assembly may have a distal end 32 and a proximal end 34. The transducer 28 may include a plurality of piezoelectric elements that are operatively or conductively connected to the flexible printed circuit 30. Each flexible printed circuit 30 may include a flexible substrate 36, a plurality of conductive wires 38 defined on the substrate 36, and a plurality of conductive pads 40. Each piezoelectric element may be operatively or conductively connected to a separate wiring 38 defined on the substrate 36 of the flexible printed circuit 30. In an exemplary embodiment, the piezoelectric element of the transducer is operatively or conductively used in a technique such as reflow (hot bar) soldering or anisotropic conductive film (ACF) bonding that uses a combination of pressure, heat and time. May be connected to the plurality of wirings 38 by soldering each wiring. In one embodiment, transducer 28 may include, but is not limited to, a 64 element linear phased array of piezoelectric composite (PZT) material. In one embodiment, transducer 28 may be housed in silicone. In one embodiment, the transducer 28 is visible with fluoroscopy or under fluoroscopy.

In the exemplary embodiment, the ultrasonic transducer assembly 12 may have 64 piezoelectric elements and a transducer 28 having four flexible printed circuits 30 operatively or conductively connected to the transducer 28. Each of the four flexible printed circuit 30, for example, may include 18 pads 40 of the wiring 38 and 18 of the individual wires 38 _N is connected operatively or electrically conductively to each individual pad 40 _N, A wiring / pad circuit is formed. In such an embodiment, 18 conductive lines 38 _1-18 and 18 conductive pads 40 _1-18 can form 18 lines / pad circuits, and the two lines / pad circuits can be ground lines. The remaining 16 wiring / pad circuits may be connected to the 16 piezoelectric elements of the transducer 28. In the exemplary embodiment, the two outermost wiring / pad circuits may correspond to ground lines, and the 16 inner wiring / pad circuits may correspond to 16 individual piezoelectric elements. For example, but not limited to, piezoelectric elements 1 to 16 may correspond to the first flexible printed circuit 30 _1, the piezoelectric element 17 to 32 may correspond to the second flexible printed circuit 30 _2, The piezoelectric elements 33 to 48 may correspond to the _third flexible printed circuit 303, and the piezoelectric elements 49 to 64 may correspond to the _fourth flexible printed circuit 304. Although the ultrasonic transducer assembly 12 has been described with _four flexible printed circuits _301-4 , the present disclosure is not intended to be so limited. Rather, the plurality of flexible printed circuit 30 _N in which remain within the spirit and scope of the desired well be used depending on, also present disclosure.

  As schematically shown in FIGS. 1, 2 and 4, an embodiment of handle 14 is described in US application Ser. No. 13 / 105,646, which is incorporated by reference in its entirety as if fully set forth herein. It may be similar to the handle described in (published November 17, 2011 as US Patent Application Publication No. 2011 / 0282176A1). In an embodiment, the handle 14 may be operated at the distal end portion of the body 16 of the catheter 10 (described in further detail below) and / or four of the ultrasonic transducer assembly 12 by manipulation of two or more control members. Can provide direction operation. As can be seen in FIG. 2, the embodiment of handle 14 may be configured to operate more than one control member, one actuator or knob 42, or first knob 42 and second knob. A plurality of actuators or knobs such as 44 may be included. As can be seen in FIG. 4, the handle 14 may have a distal end 46 and a proximal end 48. A wire harness 18 located in the lumen of the body 16 enters from the distal end 46 of the handle 14, passes through the handle 14 via the passage 50, and exits from the proximal end 48 of the handle 14. In one embodiment, a portion of the wire harness 18 may be surrounded by a protective sleeve 49 in the passage 50 of the handle 14. After the wire harness 18 passes through the handle 14, the wire harness 18 may pass through the lumen of the tubing 20. In one embodiment, the wire harness 18 may pass through the passage 50 in the handle 14 directly along a path substantially parallel to the central longitudinal axis 52 of the handle 14. In another embodiment, a portion of the wire harness 18 may be provided off the center of the handle 14 as the wire harness 18 exits the proximal end of the handle 14.

  As shown schematically in FIGS. 1 and 2, the body 16 of the catheter 10 may include a flexible tubular body 16 having a deflectable distal end portion 54 and a proximal end 56. The deflection of the distal end portion 54 of the body 16 may be actuated by the handle 14 and the deflection of the distal end portion 54 may be multi-directional. In one embodiment, the distal end portion 54 of the body 16 may be configured with four-way deflection that allows left-right and front-back deflection at an angle of at least about 120 ° in each direction. In one embodiment, distal end portion 54, which may be deflectable, may be approximately 4 and 1/2 inches long. In another embodiment, the deflectable length may be approximately 11.68 cm ± 0.50 cm. In one embodiment, the distal end portion 54 of the body 16 can be deflected back and forth, for example, by rotating a first knob 42 disposed on the handle 14. In one embodiment, the front / rear deflection may be nominally 180 ° from each other and ± 25 ° from a plane made by the neutral indicator of the handle 14 and the central axis of the distal end portion 54 of the body 16. In one embodiment, the distal end portion 54 of the body 16 can also be deflected in the left-right direction by rotating a second knob 44 disposed on the handle 14. In one embodiment, the left and right deflections may be nominally 180 ° from each other and ± 25 ° from the plane formed by the neutral indicator of the handle 14 and the central axis of the distal end portion 54 of the body 16. In another embodiment, the left and right deflection may be controlled by the first knob 42 and the deflection in the front-rear direction may be controlled by the second knob 44. In one embodiment, the body 16 may be cylindrical and non-conductive. In one embodiment, the body 16 may have a 9 French (F) diameter. In one embodiment of the body 16 having a 9F diameter, a 10F introducer may be used with the 9F body, for example for insertion into the femoral or jugular vein. In one embodiment, the body 16 may include radiopaque Pebax ™ tubing. In one embodiment, the body 16 may have a usable length (“L1”) of about 90 cm. In one embodiment, the ultrasonic transducer assembly 12 may be disposed at the distal end portion 54 of the body 16 and attached to the ultrasonic transducer assembly 12 (eg, as described in more detail below). The wire harness 18 may extend through the body 16 substantially from the distal end 24 to the proximal end 26 of the catheter 10. In one embodiment, the body 16 and the wire harness 18 extending through the body 16 can enter the opening of the handle 14.

  As described above, the wire harness 18 may pass completely through the handle 14 such that the handle 14 is between the distal end 58 of the wire harness 18 and the proximal end 60 of the wire harness 18. In one embodiment, the portion of wire harness 18 between handle 14 and proximal end 60 of wire harness 18 may be covered by tubing 20. In one embodiment, tube material 20 may be connected to connector 22 and handle 14, and tube material 20 may protect and wrap wire harness 18. In one embodiment, the tube material 20 and the wire harness 18 extending through the tube material 20 as shown in FIG. 2 has a length (“L2”) that may be approximately 110 cm long. You can do it.

  With reference to FIGS. 5-10, the wire harness 18 may include a wiring bundle 62, a distal flex circuit 64, and a proximal flex circuit 66. The wire harness 18 may be configured to electrically connect the ultrasonic transducer assembly 12 to an electronic control unit (ECU) 23, which captures and records signal data obtained from the transducer 28; In addition, various functions of the transducer 28 can be controlled including, but not limited to, providing an image based on the data of the transducer 28 via the display device 27 connected to the ECU 23.

  The wiring bundle 62 may have a distal portion and a proximal portion. The wiring bundle 62 of the wire harness 18 may include a plurality of twisted pair wirings 68 (ie, twisted wire pairs) and a shield 70 as shown in FIGS. As shown schematically in FIG. 6, each twisted pair wiring may include two wires 68A, 68B in which the individual wires 68A, 68B are each surrounded by an insulating material. Two individual wires 68A, 68B can be twisted together to form twisted pair wiring 68. The rate or frequency of twist (“R”) may be, for example, 27 times per inch, but is not limited to this. In the exemplary embodiment, the wires 68A, 68B may be 46 gauge wiring, each individual wire 68A, 68B may be color coded, and the color may be predetermined to connect to a particular circuit. In the exemplary embodiment, a plurality of twisted pair wirings 68 may be grouped together in a straight lay routing orientation, with each twisted pair wiring 68 being connected to another twisted pair wiring 68. Cannot be twisted together. The linear placement routing orientation may provide benefits such as minimizing the cross-sectional diameter of the wiring bundle 62 and / or maximizing the flexibility of the wiring bundle 62. In the exemplary embodiment, the plurality of twisted pair wirings 68 may include eight twisted pair wirings 68. The combined plurality of twisted pair wirings 68 may be secured with a shield 70. In the exemplary embodiment, shield 70 may be knitted and may have a pigtail wire 72 that runs the entire length of shield 70. In the exemplary embodiment, shield 70 may include a silver plated copper braiding. In the exemplary embodiment, shield 70 may be 46 gauge. In the exemplary embodiment, shield 70 may cover at least 90% of the length of the plurality of twisted pair wirings 68. In some embodiments, the shield 70 may have a length (“L3”) as long as 100 inches or greater. In the exemplary embodiment, one end of shield 70 may be positioned approximately ½ inch from edge 80 of distal flex circuit 64 and the other end of shield 70 is from edge 98 of proximal flex circuit 66. It may be located approximately 1/2 inch.

  As shown schematically in FIGS. 5 and 10, the distal flex circuit 64 of the wire harness 18 is a flexible printed circuit 30 that includes a flexible substrate 74, a plurality of conductive traces 76, and a plurality of conductive pads 78. It may be.

  The substrate 74 may have a generally thin thickness (cross-sectional area) that allows the substrate 74 to bend, bend and fold. The shape of the substrate 74 may be defined by a first edge 80, a second edge 82, a third edge 84, and a fourth edge 86. The first edge 80 (ie, the proximal edge) may be located closest to the shield 70 end of the wiring bundle 62. The second edge 82 (ie, the distal edge) may be disposed on the opposite side of the first edge 80. Third edge 84 and fourth edge 86 may be adjacent to first edge 80 and second edge 82, respectively, and third edge 84 and fourth edge 86 may be You may connect to the 1st edge 80 and the 2nd edge 82, respectively. In one embodiment, the substrate 74 may have a substantially rectangular shape, which is defined by a first edge 80, a second edge 82, a third edge and a fourth edge 86. Is done. In one embodiment, the substrate 74 may include a dielectric material, such as but not limited to polyimide.

  A plurality of conductive traces 76 and a plurality of conductive pads 78 may be defined on the substrate 74. The predetermined wiring 76 and pad 78 may be combined to form a wiring / pad combination configured to form a conductive circuit on the flexible circuit. The pad 78 may generally be wider than the wiring 76. In one embodiment, pad 78 may be configured to accept a solder joint to connect a particular wire to a wire / pad combination that forms a particular circuit. In another embodiment, the pad 78 may be configured to mate with a corresponding set of pads 78 disposed on one of the plurality of flexible printed circuits 30 of the ultrasonic transducer assembly 12. In one embodiment, the conductive bond between the distal flex circuit 64 of the wire harness 18 and the flexible printed circuit 30 of the ultrasonic transducer assembly 12 is connected using reflow (hot bar) soldering. Good. In another exemplary embodiment, conductivity is achieved by placing an anisotropic conductive film (ACF) between the distal flex circuit 64 of the wire harness 18 and the flexible printed circuit 30 of the ultrasonic transducer assembly 12. ACF may be used for bonding.

  In the exemplary embodiment, distal flex circuit 64 may have two sets of conductive pads 78, a first set 88 and a second set 90. Each set 88, 90 may have a plurality of conductive pads 78, where the number of pads 78 in the set is equal to the number of electrical circuits defined in the distal flex circuit 64. For example, in the exemplary embodiment, the first set 88 may have nine pads 78 and the second set 90 may have nine pads 78. Each pad 78 of the set 88, 90 may be part of a defined circuit connected by wiring 76. In other words, the first pads 78 of the first set 88 may be connected to the first pads 78 of the second set 90, and each pad 78 is connected by the wiring 76. Thus, in this embodiment with nine pads 78 per set 88, 90, there will be nine separate circuits. While the above description has described a set 88, 90 having nine pads 78, it will be understood that the present disclosure is not intended to be limited thereto. Rather, other exemplary embodiments may use any number of pads 78 per set to accommodate a desired number of electrical circuits. Accordingly, it will be understood that embodiments other than those described in detail herein remain within the spirit and scope of the present disclosure.

  In the exemplary embodiment, the first set of pads 78 may be attached to the twisted pair wiring 68 of the wire bundle 62 and the pigtail wiring 72 of the shield 70. For example, in an embodiment having a wiring bundle 62 having eight twisted pair wirings 68, each set of pads 78 of the distal flex circuit 64 may have nine pads 78. One wire 68A from each of the eight twisted pair wirings 68 may be soldered or connected to the corresponding pad 78 of the first set 88 by other bonding techniques. The other wire 68B of the twisted pair wiring 68 that is not directly connected to the first set 88 may be operatively or conductively connected to the pigtail wiring 72 of the shield 70, and the pigtail wiring 72 then It may be operatively or conductively connected to the ninth pad 78 of the first set 88. In one embodiment, the ninth pad 78 may be used for grounding purposes. In one embodiment, after the twisted pair wiring 68 is connected to either the first set 88 or the pigtail wiring 72, the connection is made by a non-conductive material such as, but not limited to, an epoxy. It may be covered, so that the connection can be protected. A second set of pads 90 disposed near the second edge 82 of the substrate 74 may be applied to an ultrasonic transducer using the techniques described above, such as, but not limited to, reflow (hot bar) soldering or ACF. May be used to operably or conductively connect to the flexible printed circuit 30 of the assembly 12; While the above embodiments have described a wire harness 18 that uses eight twisted pair wirings 68 connected to nine circuits defined on the distal flex circuit 64, any number of twisted wires may be used. Pair wiring 68 may be utilized to accommodate the required number of circuits defined on the distal flex circuit 64, and remains within the spirit and scope of the present disclosure.

  The proximal flex circuit 66 of the wire harness 18 includes a flexible substrate 92, a plurality of conductive traces 94 defined on the substrate, and a plurality of conductive pads 96, as schematically shown in FIG. Circuit 30 may be used.

  The substrate 92 may have a generally thin thickness (cross-sectional area) that allows the substrate 92 to be bent, curved and / or folded. The shape of the substrate may be defined by a first edge 98, a second edge 100, a third edge 102 and a fourth edge 104. The first edge 98 (ie, the distal edge) may be located closest to the shield 70 end of the wiring bundle 62. The second edge 100 (ie, the proximal edge) may be disposed on the opposite side of the first edge 98. The third edge 102 and the fourth edge 104 may be adjacent to the first edge 98 and the second edge 100, respectively, and the third edge 102 and the fourth edge 104 are You may connect to the 1st edge part 98 and the 2nd edge part 100, respectively. In one embodiment, the substrate 92 may have a generally rectangular shape. In one embodiment, the substrate 92 may include a dielectric material, such as but not limited to polyimide.

  A plurality of wires 94 and a plurality of pads 96 may be defined on the substrate 92. The predetermined wiring 94 and pad 96 may be combined to form a wiring / pad combination configured to form a conductive circuit on the flexible circuit. The pad 96 may generally be wider than the wiring 94. In one embodiment, pad 96 may be configured to receive a solder joint to connect a particular wire 68A to a particular circuit formed by a wire / pad combination.

  As shown schematically in FIGS. 7-8, another embodiment of the pad 96 and substrate 92 of the proximal flex circuit 66 is a printed circuit, such as a cable edge card, of the electrical connector 22. It may be configured to mate with at least one zero insertion force (ZIF) connector 106 disposed on the substrate 108. ZIF connector 106 may be configured to receive proximal flex circuit 66. A pad 96 disposed on the substrate 92 of the proximal flex circuit 66 may be disposed directly within or on the first portion 110 of the ZIF connector 106. The second portion 112 of the ZIF connection 106 may engage the first portion 110 of the ZIF connection 106, thereby providing a conductive connection between the ZIF connector 106 and the proximal flex circuit 66, as well as the proximal flex circuit. 66 substrates 92 can be physically gripped. An advantage associated with some ZIF connection systems is that this system does not require a mating half that is mated to a flexible printed circuit 30, such as the proximal flex circuit 66, thereby reducing or miniaturizing. It is possible to save space and reduce the cost of the equipment. In one embodiment, a printed circuit board 108 (such as a rigid cable edge card) having at least one ZIF connector 106 may be configured to electrically connect to the ECU 23. A printed circuit board (such as a rigid cable edge card) may be disposed within the housing 114 of the electrical connector 22. The electrical connector 22 may be connected to the ECU 23.

  As can be seen in FIGS. 5, 9 and 10, an embodiment of the proximal flex circuit 66 may have two sets of pads 96, a first set 116 and a second set 118. Each set 116, 118 may have a plurality of pads, and the number of pads 96 in the set 116, 118 matches the number of electrical circuits defined on the proximal flex circuit 66. For example, in one embodiment, the first set 116 may have eight pads 96 and the second set 118 may also have eight pads 96. Each pad 96 of the set 116, 118 may be part of a defined circuit connected by wiring 94. In other words, the first pad 96 of the first set 116 may be connected to the first pad 96 of the second set 118, and each pad 96 is connected by the wiring 94. Thus, an embodiment having eight pads 96 per set 116, 118 has, for example, eight separate circuits.

  In one embodiment, the first set 116 of pads 96 may be attached to the twisted pair wiring 68 of the wire bundle 62. For example, but not limited to, in an embodiment having a wiring bundle 62 having eight twisted pair wirings 68, the first set 116 of pads 96 of the proximal flex circuit 66 has eight pads 96. It's okay. One wire 68A from each of the eight twisted pair wirings 68 may be soldered or connected to the corresponding pad 96 of the first set 116 by other electrically connected bonding techniques. . The other wire 68B of the twisted pair wiring 68 that is not directly connected to the first set 116 of pads 96 may be connected to the pigtail wiring 72 of the shield 70 and is covered to the proximal flex circuit 66. It does not have to be connected. A pigtail wiring 72 combined with the other wire 68 B of the twisted pair wiring 68 disposed at the proximal end 60 of the wire harness 18 may be secured to the shield 70. In one embodiment, after the twisted pair wiring 68A is connected to the first set 116 of pads 96, the connection may be covered with a non-conductive material, such as but not limited to epoxy, This protects the connection. The second set 118 may be disposed near the second edge 100 and the proximal flex circuit 66 with the second set 118 of pads 96 is inserted into the ZIF connector 106 disposed on the printed circuit board 108. May be. In one embodiment, the printed circuit board 108 may be connected to, for example, a ViewMate ™ Z or ViewMate ™ II intracardiac ultrasound console manufactured by St. Jude Medical, manufactured by St. Jude Medical. It may be connected to a ViewFlex ™ catheter interface module. Although the above-described embodiments have described a wire harness 18 that uses eight twisted pair wirings 68 connected to eight circuits defined on the proximal flex circuit 66, any number of twists may be used. Pair wiring 68 may be utilized to accommodate the desired number of circuits defined on the proximal flex circuit 66.

  In various embodiments of the wire harness 18 described above, there is a single wire harness 18 that is electrically connected to an electrical connector configured to electrically connect the ultrasonic transducer assembly 12 to the ECU 23. Disclosed. However, it will be appreciated that a plurality of wire harnesses 18 may be used to electrically connect the ultrasonic transducer assembly 12 to the ECU 23 as is apparent from FIG. Various advantages of using multiple wire harnesses 18 include maximizing the flexibility of medical devices using wire harnesses 18, reducing the size of the flex circuit that implements wire harness 18 of catheter 10, and common This may include, but is not limited to, the use of scale merit by using different wire harnesses 18 in different medical devices.

  For example, but not limited to, in the previously described embodiment of the ultrasonic transducer assembly 12 having 64 piezoelectric elements and four flexible printed circuits 30 electrically connected to the transducer 28, four flexible prints. The circuit 30 has 18 individual circuits, a total of 72 circuits (64 circuits for electrically conducting signals between the piezoelectric element and the ECU 23 and 8 ground circuits). Eight individual wire harnesses 18 may be used to connect the ultrasonic transducer assembly 12 to the ECU 23, two per flexible printed circuit 30 of the ultrasonic transducer assembly 12.

As can be seen from FIGS. 9 and 10, the embodiment of the flexible printed circuit 30 of the ultrasonic transducer assembly 12 may have a ground circuit located in the outermost circuit. According to these embodiments, when connecting the wire harnesses 18A, 18B to the ultrasonic transducer assembly 12, the first wire harness 18A and the second wire harness 18B are disposed on the outermost side of the ultrasonic transducer assembly 12. It may coincide with the position of the ground circuit. The first wire harness 18A and the second wire harness 18B may differ only in the location of the ground circuit on the distal flex circuit 64. For example, as can be seen in FIG. 9, the distal flex circuit includes a plurality of circuits (eg, wire / pad circuits 76 _{1 -N} , 78 ₁₎ formed by combinations of wires 76 _{1 -N} and pads 78 _{1 -N} . _-N ). The first wire harness 18A may have ground circuits 76 _GND , 78 _GND located adjacent to the first wiring / pad combination 76 ₁ , 78 ₁ . As is apparent from FIG. 10, the second wire harness 18B may include ground circuits 76 _GND and 78 _GND located adjacent to the _Nth wiring / pad combination 76 _N and 78 _N. In both the first wire harness 18A and the second wire harness 18B, the ground circuit may be one of the outermost wiring / pad circuits. In one embodiment, the two wire harnesses 18 may be color coded. For example, the first wire harness 18A may be colored in red and the second wire harness 18B in black.

As is apparent from FIG. 3, in the embodiment in which two wire harnesses 18 are attached to each of the flexible printed circuits 30 of the ultrasonic transducer assembly 12, each flexible print of the ultrasonic transducer assembly 12. The circuit 30 can fold onto itself along a crease 120 oriented substantially parallel to at least a portion of the wiring 38. By folding the flexible printed circuit 30 of the ultrasonic transducer assembly 12, the width (“W ₁ ”) of the flexible printed circuit 30 of the ultrasonic transducer assembly 12 is reduced to a smaller width (“W ₂ ”). This width may be approximately the same width (“W ₃ ”) as the distal flex circuit 64 of the wire harness 18. The use of various embodiments of the wire harness 18 disclosed herein has the benefit that the flexibility of the body 16 is improved and / or consistent when manipulated in multiple directions by the control handle 14. Can be given.

  While only certain embodiments have been described above with some degree of particularity, those skilled in the art can make many changes to the disclosed embodiments without departing from the scope of the present disclosure. References to coupling (eg, attached, coupled, connected, etc.) should be interpreted broadly, including intermediate members of element connections and intermediate members of relative motion between elements. Yes. Thus, references to coupling do not necessarily infer that the two elements are directly connected and fixed to each other. In addition, the terms electrical connection and communication should be interpreted broadly and encompass both wired and wireless connections and communication. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the invention as defined in the appended claims.

Any patent, publication, or other disclosed material referred to herein by reference is incorporated in whole or in part as an existing definition, description, or disclosure. It is incorporated herein by reference only to the extent that it does not conflict with other disclosed materials. Also, to the extent necessary, the disclosure expressly set forth herein takes precedence over any material incorporated by reference herein. Any material, or portion thereof, is referred to as being incorporated herein by reference, but between an existing definition, description, or other disclosed material described herein and its incorporated material. It shall be incorporated to the extent that no collision occurs.

Any patent, publication, or other disclosed material referred to herein by reference is incorporated in whole or in part as an existing definition, description, or disclosure. It is incorporated herein by reference only to the extent that it does not conflict with other disclosed materials. Also, to the extent necessary, the disclosure expressly set forth herein takes precedence over any material incorporated by reference herein. Any material, or portion thereof, is referred to as being incorporated herein by reference, but between an existing definition, description, or other disclosed material described herein and its incorporated material. It shall be incorporated to the extent that no collision occurs.
The following items are the elements described in the claims at the time of international application.
(Item 1) A wire harness for a medical device including an elongated body having a lumen,
Distal and proximal portions,
Multiple twisted pair wiring, and
Shield surrounding a part of the plurality of twisted pair wirings
A wiring bundle including
A distal flex circuit connected to the distal portion of the wiring bundle configured to operably connect to an electrically controlled object;
A proximal flex circuit connected to the proximal portion of the wiring bundle configured to operably connect to an electrical connector;
Including
A wire harness sized and configured to extend substantially through the lumen of the elongated body of the medical device.
(Item 2) The wire harness according to item 1, wherein the plurality of twisted pair wirings are provided in a linear arrangement orientation.
(Item 3) The electrically controlled object is an ultrasonic transducer assembly including an ultrasonic transducer and a plurality of flexible printed circuits, and the distal flex circuit is at least one of the plurality of flexible printed circuits. The wire harness of claim 1, wherein the wire harness is configured to operably connect to one.
(Item 4) The wire harness according to item 3, wherein the ultrasonic transducer includes at least 64 piezoelectric elements.
5. The wire of claim 3, wherein the operable or conductive connection between the distal flex circuit and at least one of the plurality of flexible printed circuits is bonded or soldered. ·Harness.
(Item 6) An operable connection between the distal flex circuit and at least one of the plurality of flexible printed circuits is at least one of the distal flex circuit and the plurality of flexible printed circuits. Item 4. The wire harness according to Item 3, which is bonded with an anisotropic conductive film provided between the two.
(Item 7) The proximal flex circuit includes a flexible substrate and a plurality of conductive pads, and the flexible substrate and the plurality of conductive pads are configured to connect to a zero insertion force (ZIF) type connector. Item 1. The wire harness according to item 1.
(Item 8) The wire harness according to item 7, wherein the ZIF connector is provided on a rigid printed circuit board.
9. The wire harness of claim 1, wherein the medical device includes a handle and the wire harness is configured to extend completely through the handle.
(Item 10) The medical device includes a handle including at least one actuator;
The wire harness of claim 1, wherein the at least one actuator is configured to operate the elongated body in at least four directions by operation of the at least one actuator.
(Item 11) The wire harness according to item 1, wherein the wiring bundle includes at least eight twisted pair wirings.
(Item 12) The wire harness according to item 1, wherein the twisted pair wiring has a twist rate of at least 27 times per inch.
(Item 13) The wire harness according to item 1, wherein the shield includes a silver-plated copper braid.
(Item 14) The shield includes a pigtail wire configured for grounding, the twisted pair wiring includes a first wire and a second wire, the proximal flex circuit includes a flexible substrate and A plurality of conductive pads, wherein the first wire of the twisted pair wiring operably terminates at an individual conductive pad of the plurality of conductive pads, and the second wire is the pigtail The wire harness of item 1, wherein the wire harness is operably connected to the wire.
(Item 15)
The shield includes a pigtail wire configured for grounding, the twisted pair wiring includes a first wire and a second wire, and the distal flex circuit includes a flexible substrate and a plurality of conductive layers Including a pad, wherein the first wire of the twisted pair wiring operably terminates at an individual conductive pad of the plurality of conductive pads, and the second wire is operable to the pigtail wire The wire harness of claim 1, wherein the pigtail wire is operatively terminated at a conductive pad of the plurality of conductive pads.
(Item 16) The electrically controlled object includes at least one flexible printed circuit including a set of conductive pads, the distal flex circuit being adjacent to a distal end of the distal flex circuit. The set of conductive pads, the set of conductive pads not directly connected to the first wire of the twisted pair wiring, and the set of distal flex circuits The wire harness of claim 15, wherein the conductive pads are configured to conductively bond to the set of conductive pads of the electrically controlled subject.
(Item 17) A pair of wire harnesses for a medical device including a first wire harness and a second wire harness, wherein each wire harness is
Multiple twisted pair wiring, and
Shield surrounding a part of the plurality of twisted pair wirings
A wiring bundle including
A distal flex circuit configured to operably connect to an electrically controlled object and an electrically controlled object assembly including at least one flexible printed circuit, the electrically controlled object A distal flex circuit, wherein a target assembly is provided at a distal portion of the medical device;
A proximal flex circuit configured to operably connect to the electrical connector; and
Including
The wiring bundle operably connects the distal flex circuit to the proximal flex circuit, and the first wire harness and the second wire harness are each operatively electrically controlled. A pair of wire harnesses connected to the same flexible printed circuit of the target assembly.
(Item 18) The electrically controlled object includes at least one flexible printed circuit including a flexible substrate having a first width, and the electrically controlled object flexible substrate is a second substrate. Item 18. The wire harness of item 17, wherein the wire harness is configured to be bent or folded to have a width, and the second width is smaller than the first width.
(Item 19) A plurality of wire harness pairs for medical devices,
A wire harness pair including a first wire harness and a second wire harness, each wire harness comprising:
Multiple twisted pair wiring, and
Shield surrounding a part of the plurality of twisted pair wirings
A wiring bundle including
A distal flex circuit configured to operably connect to an ultrasonic transducer assembly comprising:
An ultrasonic transducer, and
A plurality of flexible printed circuits operatively connected to the ultrasonic transducer
A distal flex circuit disposed on a distal portion of the medical device; and
A proximal flex circuit configured to operably connect to an electrical connector configured to operably connect to the electronic control unit;
Including
The wiring bundle operably connects the distal flex circuit to the proximal flex circuit;
The first wire harness and the second wire harness are each a plurality of wires operatively connected to the same flexible printed circuit of the plurality of flexible printed circuits of the ultrasonic transducer assembly -Harness pair.
(Item 20) The wire harness according to item 19, wherein the plurality of wire harness pairs includes at least four wire harness pairs.

Claims (20)

A wire harness for a medical device comprising an elongated body having a lumen,
Distal and proximal portions,
A plurality of twisted pair wirings, and a wiring bundle comprising a shield surrounding a portion of the plurality of twisted pair wirings;
A distal flex circuit connected to the distal portion of the wiring bundle configured to operably connect to an electrically controlled object;
A proximal flex circuit connected to the proximal portion of the wiring bundle configured to operably connect to an electrical connector;
A wire harness sized and configured to extend substantially through the lumen of the elongated body of the medical device.   The wire harness of claim 1, wherein the plurality of twisted pair wirings are provided in a linear orientation.   The electrically controlled object is an ultrasonic transducer assembly including an ultrasonic transducer and a plurality of flexible printed circuits, and the distal flex circuit is operable on at least one of the plurality of flexible printed circuits. The wire harness according to claim 1, wherein the wire harness is configured to connect to the wire harness.   The wire harness according to claim 3, wherein the ultrasonic transducer includes at least 64 piezoelectric elements.   The wire harness of claim 3, wherein an operable or conductive connection between the distal flex circuit and at least one of the plurality of flexible printed circuits is bonded or soldered.   An operable connection between the distal flex circuit and at least one of the plurality of flexible printed circuits is between the distal flex circuit and at least one of the plurality of flexible printed circuits. The wire harness according to claim 3, wherein the wire harness is joined by an anisotropic conductive film provided on the wire.   The proximal flex circuit includes a flexible substrate and a plurality of conductive pads, wherein the flexible substrate and the plurality of conductive pads are configured to connect to a zero insertion force (ZIF) type connector. The described wire harness.   The wire harness according to claim 7, wherein the ZIF connector is provided on a rigid printed circuit board.   The wire harness according to claim 1, wherein the medical device includes a handle, and the wire harness is configured to extend completely through the handle. The medical device includes a handle including at least one actuator;
The wire harness according to claim 1, wherein the at least one actuator is configured to manipulate the elongated body in at least four directions by manipulation of the at least one actuator.   The wire harness according to claim 1, wherein the wiring bundle includes at least eight twisted pair wirings.   The wire harness of claim 1, wherein the twisted pair wiring has a twist rate of at least 27 times per inch.   The wire harness according to claim 1, wherein the shield includes a silver-plated copper braid.   The shield includes a pigtail wire configured for grounding, the twisted pair wiring includes a first wire and a second wire, and the proximal flex circuit includes a flexible substrate and a plurality of conductive layers Including a pad, wherein the first wire of the twisted pair wiring operably terminates at an individual conductive pad of the plurality of conductive pads, and the second wire is operable to the pigtail wire The wire harness according to claim 1, connected to the wire harness.   The shield includes a pigtail wire configured for grounding, the twisted pair wiring includes a first wire and a second wire, and the distal flex circuit includes a flexible substrate and a plurality of conductive layers Including a pad, wherein the first wire of the twisted pair wiring operably terminates at an individual conductive pad of the plurality of conductive pads, and the second wire is operable to the pigtail wire The wire harness of claim 1, wherein the pigtail wire is operatively terminated at a conductive pad of the plurality of conductive pads.   The electrically controlled object includes at least one flexible printed circuit including a set of conductive pads, wherein the distal flex circuit is provided adjacent to a distal end of the distal flex circuit. A set of conductive pads, wherein the set of conductive pads is not directly connected to the first wire of the twisted pair wiring, and the set of conductive pads of the distal flex circuit 16. The wire harness of claim 15, wherein the wire harness is configured to conductively bond to the set of conductive pads of the electrically controlled subject. A pair of wire harnesses for a medical device including a first wire harness and a second wire harness, each wire harness comprising:
A wiring bundle comprising a plurality of twisted pair wirings and a shield surrounding a portion of the plurality of twisted pair wirings;
A distal flex circuit configured to operably connect to an electrically controlled object and an electrically controlled object assembly including at least one flexible printed circuit, the electrically controlled object A distal flex circuit, wherein a target assembly is provided at a distal portion of the medical device;
A proximal flex circuit configured to operably connect to the electrical connector;
The wiring bundle operably connects the distal flex circuit to the proximal flex circuit, and the first wire harness and the second wire harness are each operatively electrically controlled. A pair of wire harnesses connected to the same flexible printed circuit of the target assembly.   The electrically controlled object includes at least one flexible printed circuit including a flexible substrate having a first width such that the flexible substrate of the electrically controlled object has a second width. The wire harness according to claim 17, wherein the wire harness is configured to be bent or folded, and wherein the second width is smaller than the first width. A plurality of wire harness pairs for medical devices,
A wire harness pair including a first wire harness and a second wire harness, each wire harness comprising:
A wiring bundle comprising a plurality of twisted pair wirings and a shield surrounding a portion of the plurality of twisted pair wirings;
A distal flex circuit configured to operably connect to an ultrasonic transducer assembly comprising:
A distal flex circuit, comprising: an ultrasonic transducer; and a plurality of flexible printed circuits operably connected to the ultrasonic transducer, the ultrasonic transducer assembly being disposed at a distal portion of the medical device;
An electrical connector configured to operably connect to the electronic control unit, and a proximal flex circuit configured to operably connect;
The wiring bundle operably connects the distal flex circuit to the proximal flex circuit;
The first wire harness and the second wire harness are each a plurality of wires operatively connected to the same flexible printed circuit of the plurality of flexible printed circuits of the ultrasonic transducer assembly -Harness pair.   The wire harness of claim 19, wherein the plurality of wire harness pairs includes at least four wire harness pairs.

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